Sodium Bicarbonate Tablets, Usp 10gr (650 Mg)

Sodium Bicarbonate Tablets, Usp 10gr (650 Mg)
SPL v4
SPL
SPL Set ID 650fa284-5829-588f-e053-2991aa0a9a0e
Route
ORAL
Published
Effective Date 2020-06-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sodium Cation (650 mg)
Inactive Ingredients
Hydrogenated Cottonseed Oil Cellulose, Microcrystalline

Identifiers & Packaging

Pill Appearance
Imprint: CG001 Shape: round Color: white Size: 11 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-04-16

Description

Active ingredient (in each tablet) Sodium Bicarbonate 10 gr (650 mg)

Purpose

Antacid


Medication Information

Purpose

Antacid

Description

Active ingredient (in each tablet) Sodium Bicarbonate 10 gr (650 mg)

Uses

relieves:

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach associated with these symptoms
Section 34088-5

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Section 42229-5

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Manufactured by:

CitraGen Pharmaceuticals, Inc.,

Fremont, CA 94538.

www.citragenpharma.com

Rev. 03/18 R-00

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if symptoms last more than 2 weeks.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking a prescription drug.

Antacids may interact with certain prescription drugs.

Section 50569-3

Ask a doctor before use if you have a sodium restricted diet.

Section 51945-4

CitraGen Pharmaceuticals, Inc.

NDC: 70369-001-01

Sodium Bicarbonate Tablets, USP 10 gr (650 mg)

ANTACID

1000 Tablets

THIS PACKAGE IS FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Warnings

Do not take more than 24 tablets for adults up to 60 years of age (or 12 tablets for adults 60 years of age and older) in a 24-hour period nor use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician.

Directions
  • do not use the maximum dosage for more than 2 weeks
  • tablets may be swallowed whole or dissolved in water prior to use
  • adults 60 years of age and over: 1-2 tablets every 4 hours, not more than 12 tablets in 24 hours
  • adults under 60 years of age: 1-4 tablets every 4 hours, not more than 24 tablets in 24 hours
Drug Facts

Active ingredient (in each tablet)

Sodium Bicarbonate 10 gr (650 mg)

Other Information

each tablet contains: sodium 178 mg

store at room temperature 15º - 30º C (59º - 86º F)

Inactive Ingredients

Hydrogenated Vegetable Oil, NF and Microcrystalline Cellulose, NF

Questions Or Comments?

Phone: +1-510-249-9066 (9AM-5PM PST, Mon-Fri); e-mail: [email protected]


Structured Label Content

Uses

relieves:

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach associated with these symptoms
Section 34088-5 (34088-5)

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Section 42229-5 (42229-5)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Manufactured by:

CitraGen Pharmaceuticals, Inc.,

Fremont, CA 94538.

www.citragenpharma.com

Rev. 03/18 R-00

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if symptoms last more than 2 weeks.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking a prescription drug.

Antacids may interact with certain prescription drugs.

Section 50569-3 (50569-3)

Ask a doctor before use if you have a sodium restricted diet.

Section 51945-4 (51945-4)

CitraGen Pharmaceuticals, Inc.

NDC: 70369-001-01

Sodium Bicarbonate Tablets, USP 10 gr (650 mg)

ANTACID

1000 Tablets

THIS PACKAGE IS FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Antacid

Warnings

Do not take more than 24 tablets for adults up to 60 years of age (or 12 tablets for adults 60 years of age and older) in a 24-hour period nor use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician.

Directions
  • do not use the maximum dosage for more than 2 weeks
  • tablets may be swallowed whole or dissolved in water prior to use
  • adults 60 years of age and over: 1-2 tablets every 4 hours, not more than 12 tablets in 24 hours
  • adults under 60 years of age: 1-4 tablets every 4 hours, not more than 24 tablets in 24 hours
Drug Facts

Active ingredient (in each tablet)

Sodium Bicarbonate 10 gr (650 mg)

Other Information (Other information)

each tablet contains: sodium 178 mg

store at room temperature 15º - 30º C (59º - 86º F)

Inactive Ingredients (Inactive ingredients)

Hydrogenated Vegetable Oil, NF and Microcrystalline Cellulose, NF

Questions Or Comments? (Questions or comments?)

Phone: +1-510-249-9066 (9AM-5PM PST, Mon-Fri); e-mail: [email protected]


Advanced Ingredient Data


Raw Label Data

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